Quality Assurance Manager

Apsida Life Science; Birmingham; Hybrid; GBP 60,000 - 80,000; Part time

Job summary

A growing biotechnology company is seeking an experienced QA Manager (Consultant) focused on GCP compliance for Phase II clinical trials. This part-time, contract role involves overseeing quality assurance activities, conducting audits, and ensuring regulatory compliance with MHRA and FDA standards. The ideal candidate will have over 7 years of experience in QA within the biotech or pharma field, with strong skills in communication and documentation. Flexibility in engagement is provided, with remote or hybrid work options available.

Qualifications

• 7+ years of Quality Assurance experience in the biotech, pharma, or CRO environment.
• Strong GCP quality background supporting Phase I–III clinical trials.
• Experience preparing for and supporting MHRA and FDA inspections.
• Demonstrated experience conducting clinical site audits and vendor audits.

Responsibilities

• Oversee GCP components of the Quality Management System (QMS).
• Perform clinical site audits, vendor audits, and internal process audits.
• Ensure ongoing GCP compliance throughout clinical trial execution.
• Serve as QA representative for inspection readiness and regulatory interactions.
• Review and approve clinical documentation related to trials.
• Support the development of SOPs and training programs.

Skills

GCP quality expertise

Communication skills

Collaboration

Documentation skills

Job description

Job Title: QA Manager (Consultant) – GCP Compliance (Biotech / Phase II)

About the Company

We are a growing biotechnology company advancing Phase II clinical programs. As we expand our clinical operations and global trial footprint, we are strengthening our Quality Management System and GCP oversight. We are seeking an experienced QA Manager (Consultant) who brings strong GCP quality expertise and hands‑on experience supporting teams through MHRA and FDA regulatory expectations.

This is a contract / part-time / fractional role with flexible engagement structure.

Role Overview

The QA Manager (Consultant) will lead GCP quality assurance activities across ongoing clinical trials, vendors, and documentation systems. The ideal candidate brings practical, scalable approaches to quality in a mid‑stage biotech environment, and can both advise strategically and execute hands‑on quality tasks.

Key Responsibilities

• Oversee and maintain GCP components of the Quality Management System (QMS) to support Phase II clinical activities.
• Perform clinical site audits, vendor / CRO audits, and internal process audits.
• Ensure ongoing GCP compliance throughout clinical trial execution.
• Serve as QA representative for inspection readiness and regulatory interactions, including MHRA and FDA expectations.
• Review and approve clinical documentation, including protocols, Investigator Brochures, monitoring plans, TMF records, deviations, and CAPAs.
• Support development and maintenance of SOPs and training programs for clinical and cross‑functional teams.
• Provide coaching and guidance to Clinical Operations, Medical, and outsourced partners.
• Support preparation, response, and CAPA follow‑up for inspections and audits.

Qualifications

Required

• 7+ years of Quality Assurance experience in biotechnology, pharma, or CRO environment.
• Strong GCP quality background supporting Phase I–III clinical trials.
• Demonstrated experience preparing for and supporting MHRA and FDA inspections.
• Experience conducting clinical site audits and vendor audits.
• Ability to evaluate and improve QMS processes in a growing organization.
• Excellent communication, collaboration, and documentation skills.

Preferred

• Experience with EU trials or global Quality oversight.
• Familiarity with TMF structure and metrics.

Engagement Details

• Consulting / Contract / Fractional role
• Estimated workload: 0.4–0.5 FTE, depending on stage and needs
• Remote or hybrid, with occasional on‑site meetings or audits as required
• Contract duration: 12 months with potential extension